Article 13

Under Article 13 (tobacco advertising, promotion and sponsorship)¹, Parties have six main obligations: prohibit deceptive promotion of tobacco products; comprehensively ban TAPS in the media; put health warnings on all TAPS; prohibit tobacco sponsorship of international events and/or the participation therein; restrict direct or indirect incentives encouraging tobacco product purchase; and, in case of a non-comprehensive ban adoption, require the disclosure to the governmental authorities of the tobacco industry’s expenditures on TAPS not yet prohibited.

Article 21

Under Article 21 (reporting and exchange of information)¹, Parties are required to report their implementation progress to the FCTC Secretariat, through the biennial submission of a report. In 2020, the Secretariat has enhanced the submission process with supporting materials, such as webinars³, step-by-step instructions⁴ and videos⁵ guiding each step of the reporting process. From the Parties’ individual reports, the Secretariat then prepares the ‘Global Progress Report on Implementation of the WHO Framework Convention on Tobacco Control’⁶, and submits it for consideration to the Conference of the Parties (the Convention’s governing body).

The report submitted by the Parties consists of a questionnaire, with sixteen questions referring to TAPS (thematic group C27) (Table 1). However, the TAPS section has a number of data entry issues^7-10. The WHO FCTC Secretariat has reported¹⁰ that some of the Parties complete both the comprehensive ban questions (C271–C272) and the questions referring only to partial advertising restrictions (C273–C2711), which contradicts the step-by-step instructions, which suggest that the latter should be completed only when comprehensive TAPS bans are not present⁴. Additionally, amongst the Parties which have a comprehensive ban, a number give negative replies to some of the following ban sub-questions on media types covered by the ban (C272)¹⁰, which suggests that the Parties’ definition of ‘comprehensiveness’ varies¹¹. Furthermore, some researchers^7-9 are skeptical of the accuracy of the reports, as the data submitted are contingent on the Parties’ selective progress reporting⁷, the assessment is more nuanced than the data suggest^8,9, and is not externally validated⁸. They also criticize the reported information as being discrepant with the existing situation, due to reporting of unrealistic policy changes in short time-periods or to under-recording of existing policies⁷.

In an effort to improve reporting, other databases have been examined^7,8,12, such as the WHO’s Report on the Global Tobacco Epidemic (MPOWER report)¹³, bespoke assessment tools have been created (e.g. Tobacco Control Scale, WHO MPOWER tobacco control score)^14,15 or assessments with triangulated information have been conducted^9,16. These alternatives have limitations too, such as the MPOWER report’s susceptiveness to both subjectivity and social desirability biases of the national experts who provide the scores^12,17, and the subjectivity of the bespoke assessment tools during the scoring process¹⁴.

The FCTC’s reporting approach may not provide an accurate reflection of the actual policy landscape. Nevertheless, creating a new system for assessing TAPS policy adoption to the WHO FCTC standard would create an additional administrative burden for both the Convention Secretariat and the Parties. Identifying ways to improve the existing reporting tool may be more time and cost effective.

This pilot study evaluates the WHO FCTC questionnaire in terms of facilitating the Parties to fully capture the implementation of Article 13. To achieve this, we recruited and interviewed WHO FCTC national focal points (NFPs – individuals working as communication entry points between the Convention Secretariat and the Parties, designated also with the task to complete the WHO FCTC questionnaire on the Party’s behalf). Our study’s aim was to gain a deeper understanding of the completion process followed by the NFPs and of the challenges encountered during the completion of the WHO FCTC questionnaire section that captures the implementation of Article 13. The findings of this investigation could become valuable for the FCTC Secretariat, the representatives participating in the Conference of the Parties, the administrative personnel of the governmental tobacco control units, as well as the researchers using FCTC data on tobacco control implementation, and the tobacco control advocates seeking opportunities to support their government in monitoring the WHO FCTC implementation and its reporting.

Study design and participants

We conducted qualitative one-to-one interviews with NFPs from low- and middle-income countries. Assessing the TAPS policy implementation in low- and middle-income countries (as those are encountering FCTC implementation challenges due to prioritization to other infectious diseases, the weaker legislative systems and the high reliance on international donor funds)^18-20 and their reporting to the FCTC Secretariat, dictated purposive sampling of NFPs from this income group. The latter was identified with the use of the World Bank’s 2020 income country classification²¹, and the list of the FCTC Parties².

In January 2021, the FCTC Secretariat facilitated our approach via an e-mail invitation to all NFPs from this group (n=81). The participation criteria were: being the individual who completed the FCTC questionnaire, having English-language competency, being employed as an NFP during the period of the interview, having access to a computer and Internet connection on the day of the interview, being available for an interview between January and March of 2021, and providing participation consent.

Due to low initial response (n=2), we prolonged the data collection period until June 2021, and sent a personalized invitation to 32 NFPs. These were proposed by the FCTC Secretariat due to their past close collaboration. As no further interest was expressed, we grouped the invitations of the 32 NFPs per WHO Region and we incentivized them by highlighting the opportunity to raise a voice for that Region. Another 8 NFPs then expressed their interest, but only 6 completed the consent form and scheduled an interview date. One NFP requested to conduct the interview in a written format, and this was granted. For the remaining 25 NFPs, 5 initially agreed to participate but later the communication was discontinued, one was relocated to another governmental department, one declined participation and 18 never followed up the communication attempts. We concluded the recruitment process in mid June 2021.

A total of 9 NFPs participated in the pilot study. The majority were males (67%), aged 31–54 years (mean: 44.7). They represented at least one WHO Region (two from each of Africa, Americas, and Europe, and one from each of Eastern Mediterranean, South-East Asia and Western Pacific) and their experience of completing the FCTC questionnaire ranged 2–11 years (mean: 5.6). Eight of the participants agreed to participate in a one-to-one interview of duration 30–60 minutes (average: 49) and one participant, due to language barriers and heavy daily workload, answered the interview guide in a written format.

Data collection

The lead author carried out one-to-one, semi-structured interviews with all consenting participants. The interview guide (Supplementary file) was first pilot-tested with a former WHO regional employee with FCTC related responsibilities. The first section of the guide covered the participant’s role as an NFP (e.g. task responsibilities, training and instructions received), while the second was a cognitive interview evaluating the meanings and processes used by the participants to answer each of the FCTC questions. The participants were also provided with the opportunity to document any encountering challenges, both for individual questions and for the overall questionnaire, and to suggest improvements for future FCTC questionnaire versions. All interviews were conducted via Microsoft Teams, audio recorded via a digital dictaphone, transcribed, and then anonymized.

Data analysis

A thematic framework analysis approach²² was used to analyze the data. The first two authors conducted the analysis through an iterative process of five main stages. The first stage of the analysis involved data familiarization by again listening to the audio-recorded interviews and reading all the interview transcripts, to obtain a broad overview of the participants’ responses. At the second stage, the first two authors compiled a list of topics emerging from the interviews (see analytical process in Supplementary file). Thereafter, they returned to the transcriptions, and independently made the identified topics more descriptive (see initial categories and themes in Supplementary file). The two authors met again to discuss them and to form the initial thematic framework (coding index). At the third stage, the two researchers independently applied the index to all transcripts using NVivo software, version 12. The researchers, following discussions, summarized the coded data under refined categories and synthesized the final themes (Supplementary file). This process set up the final analytical Framework (Table 2). At the fourth stage, the two authors independently applied the Framework to all transcripts to ensure its validity, and then discussed and resolved any discrepancies. Following this step, they charted the data in a matrix, with the main themes allocated to each row on the chart and each transcript assigned to a specific column (see full matrix in Supplementary file). The two authors used this matrix to identify the differences and similarities across transcripts and within themes. At the final stage, any identified patterns between the themes and categories were discussed amongst the first two authors, interpreted²² in the context of the reported criticism^7-9 of the FCTC’s reporting process and then discussed in this manuscript. Throughout the analysis, the authors iteratively reflected on the original data and the previous analytical stages, to ensure the study participants’ views were represented and to reduce the possibility of misinterpretation. This pilot study was reported according to the consolidated criteria for reporting qualitative research (COREQ) (Supplementary file)²³.

Use of different resources

The TAPS section of the FCTC questionnaire includes three groups of questions. For the first two groups of questions (adoption and implementation of a comprehensive ban, and existence of TAPS restrictions), most participants based their answers on the content and language of the national legislation. Respectively for the latter group of questions (cooperation existence with other Parties, and utilization of the FCTC’s Guidelines), the participants drew from their own knowledge and experience when providing their answers. However, the resources used for the completion of the first two question groups was different amongst participants. Three participants (of the total nine) did not use the national legislation or when they did, they added supplementary approaches. Namely, as part of their answers’ justification, they used the TAPS compliance related information, or consulted the previous submitted reports and updated them according to any new adopted legislation or new TAPS surveillance data, whilst one participant used their own experience for completing the questions:

‘… so I used my experience from filling similar questionnaires.’ (NFP, 1839)

The differences could be explained by the questionnaire completion instructions. The FCTC Secretariat provides relevant instructions on its website^4,5, nevertheless participants did not mention using it. One participant avoided it due to the already existing administration burden:

‘... I do not want to lie. I do not do that. Because I have a lot of things under…’ (NFP, 1239)

Instead, the participants chose other methods. They mentioned learning the process either directly from others (e.g. trained by the predecessor) or indirectly (e.g. own completion experience, attending FCTC’s knowledge exchange seminars) or by combining their own understanding of the completion process with their predecessors’ instructions.

Some study participants had support from a tobacco control team, while a few worked alone. All participants reported liaising with others (e.g. from other ministries, tobacco control committees, parliamentarians) for consultation purposes during the completion process; nevertheless the legislation content was always prioritized for answer justification over these consultations. In rare occasions of a disagreement during the questionnaire completion, the solution was found via team discussions, negotiations with policymakers or by training the individuals from the other agencies on Article 13:

‘I … consult my team for providing a particular answer within the report. If there [are any] disagreements among the team for answering any particular question, I use [the] majority for resolving them ...’ (NFP, 1335)

Compounding complexities

The completion process is burdened by the pre-existing struggles accompanying the NFPs’ role (e.g. overwhelming workload, limited human capacity and resources available, plethora of received information and requests). Thus, the participants identified the reporting process, including the data collection and verification, as time burdensome and the timeframes set by the FCTC Secretariat as not always clear. As an NFP highlighted, this task could become even more challenging for novice NFPs with insufficient experience:

‘Many focal points … are changing [often]. If the new focal points … do not know what the Secretariat is, they do not know what the Convention is, they do not know what reporting is … it is impossible.’ (NFP, 614)

The complexities existing within the FCTC questionnaire do not ease the situation. During the interview, two questionnaire related barriers were identified. Firstly, the struggle to understand due to: a) language barriers, b) the question or legislation lack of clarity, and c) the unknown/unclear words existing within the questionnaire (e.g. definitions of the words ‘Parties’, ‘cooperation’, ‘brand stretching’). Whenever this struggle was encountered, participants provided their answers according to their own interpretation of the question or to the partial interpretation of the national legislation:

‘Cross-border advertising… It is not clear to me. What does it mean? Is it for the internet? What is the difference?’ (NFP, 614)

The second issue was the challenge of fitting the available information from the local legislation on the questionnaire’s binary (yes/no) available options. Some participants found it difficult to answer some questions, due to: a) the absence of requested information, b) legislative changes during the questionnaire completion period, or c) the multiple ways to interpret the questions which was influenced by available information:

‘So, I do not know in this context if I should answer “yes” or “no” ... what is the correct [answer].’ (NFP, 1839)

The participants overcame these barriers by using other non-health related legislations (in the case of a law’s absence) or guessing the most appropriate answer (yes/no) on the questionnaire based on the available information.

The two challenges are associated with the structure of the questionnaire. The current format of binary answers (yes/no) is restrictive. For example, whenever the legislation text or the survey’s question, or the results from the monitoring TAPS data, could be interpreted in multiple ways, the participants were forced to deploy their own interpretation about which option describes the legislative situation better:

‘So if your process is looking on the one but not the other, it can be “yes” to one and “no” to the other … There is a lot of information.’ (NFP, 1827)

Similarly, the format of the first question (C272), which cross-examines the existence of a comprehensive TAPS ban, created a dilemma for some participants, since a negative answer prevents from informing the FCTC Secretariat about the existence of some of the TAPS bans:

‘If I answer “no”, I will need to skip … the [section] C272 ... But within this block of questions there are questions that I can answer “yes”.’ (NFP, 1839)

The structure of the questionnaire also created some challenges in regard to the connection between some of the questions. This happened to the set of questions which asked about the existence of TAPS restrictions (questions C273–C2711). The first question (C273) asks about the existence of a constitution or constitutional principles precluding the adoption of comprehensive ban. However, all the following questions about the specific restrictions (C274–C2711) start with a dash and the restriction (e.g. ‘–applying restrictions on all TAPS?’):

‘My question is if there is a link between question C273 and C274 … I do not know … this is a bit tricky…’ (NFP, 1839)

Hence, some participants answered these questions based on the existence of constitutional precludes and not the existence of a restriction, as the FCTC Secretariat requests⁴. Similar instances, of missing the connection from the initial question occurred in the C272 sub-questions – which inquire about the TAPS ban coverage; as well as in C2712 and C2713 – which refer to the existence of cooperation with other countries for tackling cross-border advertising and the penalties for cross-border advertisements. Missing this connection, the participants could misunderstand the questions’ true aim and provide answers which did not necessarily represent the questioned legislative environment.

Supporting mechanisms

Despite these complexities, the informants also acknowledged mechanisms which made the questionnaire easier to be completed. The most significant mechanism was when a participant’s Party had integrated the FCTC’s Article 13 within the law and had the Article’s Guidelines translated and adapted to the local context, as reference to those documents made the completion process unchallenging. Other mechanisms identified were the questionnaire’s positive features (e.g. number of included questions), the NFPs’ collaborations with their teams or the other agencies, attendance at FCTC related workshops, and their own personal characteristics (e.g. experience, knowledge, expertise). However, the participants also acknowledged that not all supportive mechanisms apply for every NFP:

‘It is not difficult to be answered [by] the person who has some experience in tobacco control. … For me [it is] not a problem … maybe for other people it is not [the] same.’ (NFP, 614)

Recommendations for questionnaire and for those completing it

While some participants found the questionnaire ‘very simple and very straight forward’, many requested changes on the questionnaire’s clarity and structure. Participants who requested improvements on the questions’ clarity, struggled to suggest how this could be achieved. Only one participant suggested that the FCTC Secretariat needs to provide the definition of important words within each question, and completion instructions for the questions referring to corporate social responsibility, cross-border TAPS originating from Party’s territory, and banning the same forms of cross-border TAPS entering the Party’s territory for which domestic regulation apply (all sub-questions of C272). The same participant suggested that such definitions would help the NFPs to understand the questions and answer as the FCTC Secretariat requires. Furthermore, one participant expressed the opinion that the FCTC Secretariat should provide the questionnaire, its instructions and the FCTC website in more languages, while another recommended that whatever changes the FCTC Secretariat makes, they should pilot them first with the Parties and receive feedback about their appropriateness.

Three alterations to the questionnaire’s structure were proposed. Firstly, the removal of the restriction between questions C271 and C272 (‘If you answered “No” to question 3.2.7.1, please proceed to question 3.2.7.3.’), which provides a new block of questions only to the Parties that have a comprehensive ban on TAPS. Thus, everyone will have the opportunity to inform the FCTC Secretariat about the existing TAPS bans. Secondly, in question C272 (‘If you answered “Yes” to question 3.2.7.1, does your ban cover:’), it was suggested the repetition of its latter part in each of the following sub-questions which specify the TAPS types. Similarly, for the block of questions which refer to TAPS restrictions (C274–C2711), the participants suggested replacing any existing dashes with text clearly stating what information is required:

‘My question is if there is a link between question C273 and C274. … if [in all sub-questions it asks whether] we have a restriction on tobacco advertising … [then it is] “yes”. But in the constitution, we do not have such a restriction!’ (NFP, 1839)

Lastly, some participants suggested that the questionnaire could be improved by providing explanations beyond the binary answer, such as through an open-ended section:

‘There is a lot of information. And I think it should be some more responding options rather than just a simple “yes” or “no”.’ (NFP, 1839)

The study participants also suggested recommendations for those undertaking the NFP role. They suggested that every NFP should gain legislation expertise (local, on the Convention and on the Guidelines for Article 13) and be as close to the legislation’s content as possible during the completion process. Expanding expertise to other relevant legislation, outside of health policy, would also be beneficial. The participants also proposed that their colleagues attend small refresher trainings conducted by the FCTC Secretariat as these reduce time reading documents and also support knowledge exchange between the Parties. Furthermore, they recommended the involvement of others in the completion process, such as people from other governmental departments and the country’s WHO office:

‘… my proposal for these countries is to use the power of the WHO [country] office … to … assist the national focal point to develop and complete the questions.’ (NFP, 1129)

Strengths and limitations

Our pilot study has some limitations. Due to the low participation rate, these data are not necessarily generalizable across all NFPs from low- and middle-income FCTC Parties. The presence of self-selection bias between our study participants should be acknowledged and thus the pilot study results need to be treated with the caution. Despite our efforts to for achieve high participation rates, these remained low. The participants were public officials, and hence we could not provide any incentives (e.g. vouchers) to increase participation. During the recruitment process of future investigations, anonymity and collection of non-sensitive data should be assured, clarification of own and field’s contribution, and that extensive expertise is not necessary for participation should be highlighted. Language barriers that prevent additional study participation could be mitigated by involving a multi-lingual research team.

The data’s generalizability to typical times should also be considered. The pilot study was conducted during the COVID-19 pandemic, which might have influenced the NFPs’ participation due to the increased workload and the specific challenges reported. The challenges described here, represent the opinions and recommendations of the people who were holding their country’s NFP position at the time of the study and for the FCTC questionnaire’s version circulated the same period. Hence, any challenges expressed here may differ from those that will be expressed from the participants’ successors who may have different professional background and expertise on the TAPS subject. Additionally, the format of the FCTC questionnaire can be updated at any moment, thus the challenges described here could be eliminated and new ones generated. Future studies could explore potential changes in the NFPs’ opinions over time or over updated versions of the WHO FCTC questionnaire.

Despite these limitations, our pilot study also has some strengths for the general literature. To the authors’ best knowledge, this was the first ever investigation targeted to the specific specialists group. The small sample size allowed us to dedicate more time with each participant for every question existing within the section of the FCTC questionnaire that refers to Article 13. This helped the participants to explain their own meanings and processes, as well as to reveal struggles that were internalized until today. Our sample’s homogeneity revealed that the identified challenges were not associated with the participants’ specific WHO Region. In contrast, they seem to be influenced more by the personal interpretation of the questions, which was determined by the training received and the habits developed over the years with the FCTC questionnaire completion. The study participants provided an extensive list of recommendations (Figure 2). These should be acknowledged at FCTC level, as the outcomes from this questionnaire inform researchers and the Conference of Parties about the current state of the TAPS policy environment, are used as good practices exchange, and form the direction of the global tobacco control policy agenda. Our findings are also important for the national tobacco control advocates, as the challenges mentioned here create opportunities for initiating or further developing collaborations with the NFPs. This can be achieved by the advocates supporting the NFPs’ task, either by monitoring the accuracy of the Article 13 implementation reporting, or by facilitating novice NFPs with their training, informing them about the issues existing within the questionnaire, and supporting them with the proper interpretation of the questions.

Figure 2

Summary of recommendations for the FCTC Secretariat, the questionnaire monitoring the implementation of the FCTC and the administrative personnel of the governmental tobacco control units, as provided by the national focal points that participated in interviews conducted in 2021